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Dornier MedTech

FDA UDI

Class II (US FDA UDI)

by Dornier MedTech GmbH

Identity

Trade Name
Dornier MedTech FDA UDI
Generic Name
Electromechanical lithotripsy system, extracorporeal FDA UDI
Device Name
Gemini Lithotripter, 65 KW FDA UDI
Model / Reference
Gemini FDA UDI
Description
Gemini Lithotripter, 65 KW FDA UDI

Identifiers

Catalog Number
K1032810 FDA UDI
Primary DI / UDI-DI
04049957003265 FDA UDI
510(k) Number
K121656 FDA UDI
FDA Product Code
LNS FDA UDI
GMDN Term
Electromechanical lithotripsy system, extracorporeal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5990 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electromechanical lithotripsy system, extracorporeal

Dornier MedTech by Dornier MedTech GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromechanical lithotripsy system, extracorporeal.

Cleared under the same submission

K121656 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dornier MedTech GmbH

Sources (1)

  • FDA UDI d464996a-347c-4219-881e-c92fd9a44693 35 fields · synced May 30, 2026